CAPSAICIN EXTERNAL ANALGESIC- capsaicin cream 
AvPAK

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Capsaicin Cream 0,025%

Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

External analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

Do not use

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad

When using this product

  • you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • avoid contact with the eyes, lips, nose and mucous membranes
  • do not tightly wrap or bandage the treated area
  • do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 18 years of age and older:

Children under 18 years: ask a doctor

Other information

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Questions or comments?

1-855-361-3993

Manufactured for:
AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

60

CAPSAICIN  EXTERNAL ANALGESIC
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-195
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PETROLATUM (UNII: 4T6H12BN9U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50268-195-601 in 1 CARTON12/08/2022
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/08/2022
Labeler - AvPAK (832926666)

Revised: 12/2022
Document Id: ef5a4143-6e96-80c8-e053-2a95a90a6565
Set id: ef5a3846-1d2f-7023-e053-2a95a90ad716
Version: 1
Effective Time: 20221208
 
AvPAK